EXOGEN

Main information

  • Trade name:
  • EXOGEN - Stimulator, bone growth, ultrasonic
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • EXOGEN - Stimulator, bone growth, ultrasonic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217833
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217833

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - EXOGEN - Stimulator, bone growth, ultrasonic

ARTG entry for

Medical Device Included Class IIa

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

28/11/2013

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Bioventus LLC

4721 Emperor Boulevard Suite 100

Durham, NC, 27703

United States Of America

Products

1. EXOGEN - Stimulator, bone growth, ultrasonic

Product Type

Medical device system

Effective date

28/11/2013

GMDN

18154 Stimulator, bone growth, ultrasonic

Intended purpose

The ultrasound bone healing system is indicated for the non-invasive treatment of osseous defects

conservatively or surgically treated (excluding vertebra and skull) that includes: Treatment of delayed

unions and non-unions; Accelerating the time to heal of fresh fractures; Treatment of stress fractures;

Accelerating repair following osteotomy; Accelerating repair in bone transport procedures; Accelerating

repair in distraction osteogenesis procedures; Treatment of joint fusion. The system transmits a

low-intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the

patient during the treatment. The patient administers treatment, once daily, for 20 minutes, or as

prescribed by a physician. The ultrasound bone healing system consists of one EXOGEN device, a

charger, a gel bottle, a strap and a SD Treatment Card.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.12.2017 at 04:51:51 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information